OSSICODONE 10 mg /Ml Roztwór Do Wstrzykiwań Lub Infuzji

Treść ulotki

1. Ossicodone Molteni 50 mg/ml, injectable solution or infusion
   1. What is Ossicodone and what is it used for
   2. What you need to know before you are given Ossicodone
   3. How to take Ossicodone
   4. Possible side effects
   5. How to store Ossicodone
   6. Contents of the pack and other information
2. Ossicodone Molteni 50 mg/ml, injectable solution or infusion solution
3. Ossicodone Molteni 10 mg/ml, injectable solution or for infusion
   1. What is Ossicodone and what is it used for
   2. What you need to know before you are given Ossicodone
   3. How to take Ossicodone
   4. Possible side effects
   5. How to store Ossicodone
   6. Contents of the pack and other information

Ossicodone Molteni 50 mg/ml, injectable solution or infusion

Ossicodone hydrochloride

Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Ossicodone is and what it is used for
• 2. What you need to know before you are given Ossicodone
• 3. How Ossicodone will be given to you
• 4. Possible side effects
• 5. How to store Ossicodone
• 6. Contents of the pack and other information

1. What is Ossicodone and what is it used for

The abbreviated name ‘Ossicodone’ is used. It contains the active ingredient oxycodone hydrochloride. This
belongs to a group of medicines called painkillers (or ‘analgesics’).
Oxycodone is used for moderate to severe pain.

2. What you need to know before you are given Ossicodone

You must not be given Ossicodone if:

• you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• you have breathing problems, such as ‘severe chronic bronchial obstruction’, ‘severe asthma’ or have ‘severe respiratory depression’ causing shortness of breath, cough or slower and weaker breathing;
• you have severe abdominal pain or part of the intestine is not working properly (‘paralytic ileus’);
• you have heart problems caused by long-term lung disease (‘cor pulmonale’);
• you have moderate to severe liver problems;
• you have frequent constipation;
• you are under 18 years of age.

If any of the above warnings apply to you, do not use Ossicodone. If you are not sure, talk to your
doctor, pharmacist or nurse before you are given Ossicodone.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if:

• you are elderly or debilitated;
• you have reduced thyroid function (‘hypothyroidism’) - you may need a lower dose;
• you suffer from myxedema (a thyroid disorder, characterized by dryness, coldness and swelling of the skin, affecting the face and legs);
• you have a head injury, severe headache or feeling unwell - this could indicate an increase in pressure in the head;
• you have a reduced blood volume (‘hypovolemia’); this can occur as a result of severe internal or external bleeding, severe burns, excessive sweating, severe diarrhea or vomiting; you have low blood pressure (‘hypotension’);
• you have mental disorders resulting from intoxication (‘toxic psychosis’);
• you have gallbladder or bile duct disorders;
• you suffer from inflammation of the pancreas (which can cause severe pain in the abdomen or back);
• you have inflammatory bowel disorders;
• you have prostate problems;
• you feel weak or have dizziness, nausea or vomiting or have lost weight - these may be symptoms of adrenal gland dysfunction;
• you have breathing problems, such as ‘severe lung disease’ causing shortness of breath and cough;
• you have previously experienced withdrawal symptoms such as agitation or anxiety, tremors or sweating when you stopped taking alcohol or medicines;
• you have kidney problems;
• you have liver problems. If any of the above warnings apply to you (or you are not sure), talk to your doctor before you are given this medicine.

Tolerance, dependence and abuse
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers
can reduce the effectiveness of the medicine (you get used to the medicine, a phenomenon known as tolerance).
Repeated use of Ossicodone can also cause dependence, abuse, and addiction which can lead to
a potentially fatal overdose. The risk of these undesirable effects may increase with a
higher dose and a longer duration of use.
Dependence or abuse can make you feel like you no longer have control over how much medicine you
need to take or how often you need to take it. You may feel you need to continue taking the
medicine, even when it doesn't help relieve the pain.
The risk of becoming dependent or addicted varies from person to person. You may be at a
higher risk of becoming dependent or addicted to Ossicodone if:

• you or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”);
• you are a smoker;
• you have had mood disorders (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses. If any of the following signals appear while you are taking Ossicodone, this may indicate that you have become dependent or addicted:
• you need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you are using the medicine for reasons other than those prescribed, for example “to stay calm” or “to aid sleep”;
• you have repeatedly tried, without success, to stop or control the use of the medicine;
• when you stop taking the medicine you feel unwell, and you feel better after resuming it (“withdrawal effects”). If any of these signals appear, see your doctor to discuss the best treatment path for you, including when it is appropriate to stop treatment and how to do so safely (see section 3 “If you stop taking Ossicodone”).

Breathing-related sleep disorders
Ossicodone can cause breathing-related sleep disorders, such as sleep apnea (pauses in
breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms
may include pauses in breathing during sleep, nighttime awakenings due to labored breathing,
difficulty staying asleep, or excessive daytime sleepiness. If you or another person observe
these symptoms, see your doctor. The doctor may consider reducing the dose.

Children and adolescents
Do not use the medicine in children under 18 years of age.

For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.
Other medicines and Ossicodone
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines
including herbal medicines. This is because Ossicodone can change the effect of other
medicines. Other medicines can also change the effect of Ossicodone.
The concomitant use of Ossicodone Molteni and sedatives such as benzodiazepines or medicines related
to them increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can
be life-threatening. For this reason, concomitant use should only be considered when
other treatment options are not possible.
However, if your doctor prescribes Ossicodone Molteni together with sedatives, the dose and duration of
concomitant treatment must be limited by your doctor.
Tell your doctor about all the sedatives you are taking and carefully follow your
doctor's dosage recommendations. It may be helpful to inform friends or family to be aware of
the above signs and symptoms. See your doctor if you experience these symptoms.
The risk of side effects increases with the intake of antidepressants (such as citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can
interact with oxycodone and you may experience symptoms such as involuntary and rhythmic muscle
contractions, including the muscles that control eye movements, agitation, excessive sweating, tremor,
exaggerated reflexes, increased muscle tension, and a temperature above 38°C. See your doctor
if you experience these symptoms.

Do not use this medicine and tell your doctor or pharmacist if you are taking:

• medicines called ‘monoamine oxidase inhibitors’, such as tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid.

Tell your doctor or pharmacist if you are taking:

• some types of antidepressant medicines called monoamine oxidase inhibitors or if you have taken these medicines in the last two weeks;
• sleeping pills, such as tranquillizers, hypnotics or sedatives including benzodiazepines;
• medicines for depression;
• medicines for mental disorders, such as phenothiazines or antipsychotics;
• other potent painkillers or ‘analgesics’;
• medicines that relax muscles;
• medicines for high blood pressure;
• medicines for infections, such as clarithromycin, erythromycin or telithromycin;
• medicines for fungal infections, such as ketoconazole, voriconazole, itraconazole or posaconazole;
• a type of medicine for HIV called ‘protease inhibitors’, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• rifampicin (for the treatment of tuberculosis);
• carbamazepine (a medicine for the treatment of seizures and convulsions, and some types of pain);
• phenytoin (a medicine for the treatment of seizures and convulsions);
• cimetidine, used for stomach ulcers, indigestion or heartburn;
• quinidine, used for fast heartbeat;
• anaesthetics, used before an operation or medical procedure;
• an herbal remedy called St John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines for the treatment of Parkinson's disease.

If any of the above conditions apply to you (or you are not sure), talk to your doctor or pharmacist
before you are given this medicine.

Ossicodone with food, drinks and alcohol

• Do not drink grapefruit juice while being treated with Ossicodone.
• Do not drink alcohol while being treated with Ossicodone. This is because it can cause drowsiness or increase the risk of serious side effects such as shallow breathing with the risk of respiratory depression and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
This medicine should not be used during pregnancy unless expressly
advised by your doctor, and should not be given during labour, as slow and shallow breathing (respiratory
depression) or withdrawal symptoms may occur in the newborn.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before
you are given this medicine.

Breastfeeding
Do not breastfeed while taking Ossicodone. This is because the drug can pass into breast milk.

Driving and using machines
Ossicodone can cause side effects such as drowsiness, weakness,
dizziness or loss of consciousness. These are more common at the beginning of treatment or when switching to a higher
dose. If you experience these symptoms, do not drive vehicles or use tools or machinery.

Ossicodone contains sodium
Ossicodone contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. How to take Ossicodone

Before starting treatment and regularly during treatment, your doctor will talk to you about what you can
expect from using Ossicodone, when and for how long you should take it, when to contact the
doctor and when you should stop taking it (see also “If you stop taking Ossicodone”).
Ossicodone will be administered to you by a doctor or nurse. The injection must be performed immediately
after opening the vial.

Administration of the medicine
The injection can be administered in 3 ways:

• into a vein over a period of 1 to 2 minutes;
• with a subcutaneous needle;
• via ‘drip’ (infusion). How much medicine will be administered to youThe doctor will calculate the correct dose. The dose and frequency of injection administration can be modified depending on the intensity of the pain. Usually, the initial dose depends on the type of injection and will be calculated by the doctor. Generally, the initial doses are:
• single injection intravenously, usually from 1 to 10 mg, administered slowly for 1-2 minutes. The doses will be administered at least 4 hours apart;
• single injection with a thin needle into the subcutaneous tissue, the recommended initial dose is 5 mg and is generally administered every 4 hours. Via ‘drip’ (also called infusion):
• an intravenous infusion, usually the initial dose is 2 mg per hour;
• an infusion with a thin needle into the subcutaneous tissue, usually the initial dose is 7.5 mg per day;
• a self-controlled infusion (‘patient-controlled analgesia’ or ‘PCA’), the dose depends on your weight (0.03 mg per kg of body weight). The frequency of drug administration will be established by the doctor or nurse. If pain persists during the intake of Ossicodone, contact your doctor, pharmacist or nurse. Use in children and adolescentsThe medicine should not be used in case of age less than 18 years. Patients with kidney or liver problemsContact your doctor, pharmacist or nurse if you suffer from kidney or liver problems. This is because you may be given another medicine or a lower dose of ossicodone. If you are given too much Ossicodone or if the medicine is used by someone elseDo not use a dose of ossicodone higher than that prescribed by your doctor. If in doubt, check with your doctor or pharmacist. If you think you have been given too much medication (‘overdose’), inform your doctor immediately and go to the hospital immediately. Bring the medicine packaging with you. Do not drive vehicles and do not do anything that requires you to remain vigilant. In case of an overdose of the drug, the following symptoms may appear:
• reduction in pupil size;
• slower or weaker breathing than normal (respiratory depression);
• drowsiness or loss of consciousness;
• loss of muscle tone (hypotonia);
• slowed pulse rate;
• lowering of blood pressure;
• a brain condition (known as toxic leukoencephalopathy). In severe cases, an overdose can lead to fainting (‘loss of consciousness’) or death. If you stop taking OssicodoneDo not suddenly stop using this medicine unless your doctor has told you to. If you want to stop using this medicine, discuss it with your doctor first. The doctor will be able to tell you the correct way to do it. Usually, the dose must be reduced gradually, in order to avoid unwanted effects. The following symptoms may occur if you suddenly stop using this medicine:
• state of anxiety or agitation;
• palpitations;
• tremor;
• sweating.

For further information on the use of this medicine, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this injection can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Stop taking Ossicodone and contact your doctor immediately if any of the following
serious side effects occur:

• allergic reactions - symptoms may include sudden wheezing, difficulty breathing, swelling of eyelids, face or lips, skin rash or itching - these may affect the whole body;
• breathing problems (symptoms may include slow and shallow breathing).

If you experience any of the above-mentioned serious side effects, stop taking
ossicodone and contact your doctor immediately.

Other side effects
Contact your doctor, pharmacist or nurse if any of the following side effects occur:

Very common:may affect more than 1 in 10 people

• constipation - your doctor may prescribe a medicine to help you with this problem;
• Nausea or vomiting - usually disappear within a few days. If this does not happen, your doctor may prescribe you medicines that can help;
• drowsiness - this is more likely to happen at the beginning of treatment or when the dose is increased, but should disappear after a few days;
• headache;
• dizziness;
• itching.

Common:may affect up to 1 in 10 people

• dry mouth, loss of appetite, indigestion, pain or discomfort in the stomach, diarrhea;
• confusion, depression, weakness, tremors, lack of energy, fatigue, anxiety or nervousness, difficulty sleeping, strange thoughts or dreams;
• wheezing or difficulty breathing, shortness of breath, inability to cough normally;
• skin rash;
• sweating. Uncommon:may affect up to 1 in 100 people
• allergic reactions;
• difficulty breathing;
• fast and irregular heartbeat, flushing;
• feeling dizzy;
• seeing or hearing things that are not real (hallucinations), mood swings, unpleasant or uncomfortable feeling of euphoria, restlessness, agitation or general malaise, memory loss;
• difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, convulsions, changes in vision, fainting, unusual muscle stiffness or relaxation, involuntary muscle contractions;
• dry skin, severe scaling or flaking of the skin;
• dehydration, feeling thirsty, chills, sweating of hands, ankles or feet;
• redness of the face, decreased pupil diameter, muscle spasms, high temperature;
• difficulty swallowing, belching, hiccups, flatulence, a condition in which the intestine does not work properly (ileus), stomach problems, changes in the taste of food;
• difficulty urinating, problems with erection, decreased sexual desire, low levels of sex hormones in the blood (hypogonadism, detectable by blood tests);
• needing to take higher doses of the medicine than normal to get the same amount of pain relief (tolerance): as with all strong painkillers, there is a risk of becoming dependent or tolerant to this medicine, withdrawal symptoms (see section 2 “Warnings and precautions”);
• changes in liver function tests, biliary colic.

Rare side effects

• low blood pressure
• feeling faint, especially when getting up;
• urticaria

Frequency not known:frequency cannot be estimated on the basis of available data

• increased sensitivity to pain;
• aggression
• dental caries
• absence of menstrual cycle
• a blockage of bile flow from the liver (cholestasis). This can cause itching of the skin, yellowish skin, very dark urine and very pale stools;
• Long-term use of Ossicodone Molteni during pregnancy can cause potentially fatal newborn withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and altered sleep patterns, high-pitched crying, tremors, diarrhea, and failure to gain weight.
• Sleep apnea (pauses in breathing during sleep).

If any of these side effects occur, contact your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Ossicodone

Keep this medicine out of the sight and reach of children. Store this medicine in a secure location, inaccessible to others. It may cause serious harm and be fatal to people for whom it was not prescribed.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after “Exp.”.
This medicine does not require any particular storage temperature. Store in the original packaging to protect the medicine from light. Once the vial has been opened, the injection must be administered immediately. Any unused medicine must be disposed of immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossicodone contains

• The active ingredient is oxycodone hydrochloride.
• The other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, dilute hydrochloric acid, sodium hydroxide, water for injections. Description of the appearance of Ossicodone and content of the packThis injection is a clear and colorless solution supplied in transparent glass vials. The 50 mg/ml concentration is available in vials containing 1 ml of solution (containing 50 mg of oxycodone hydrochloride). Marketing authorization holder and manufacturer
• L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA - Strada Statale 67, Fraz. Granatieri - 50018 Scandicci (Florence) – Italy Tel: +3905573611 Fax: +39055720057 e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Oxycodone Molteni 50 mg/ml, solution injectable or pour perfusion France
Oxycodone Molteni 50 mg/ml, solution for injection or infusion United Kingdom
Oxycodone Molteni Poland
 ----------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only

Ossicodone Molteni 50 mg/ml, injectable solution or infusion solution

Ossicodone hydrochloride

Molteni 50 mg/ml, injectable solution or infusion solution.

Dosage and administration route

Dosage:
The dose must be adjusted based on the intensity of the pain, the patient's general condition, and previous or ongoing therapeutic treatment.

Adults over 18 years:
The following initial doses are recommended for patients not previously treated with opioids. The initial dose must be adjusted based on previous or ongoing therapeutic treatment (especially if the patient has been previously treated with other opioids), the patient's general condition, and the intensity of the pain. If pain relief is insufficient or the intensity of the pain increases, it may be necessary to gradually increase the dose.

• i.v. (bolus):dilute in 0.9% sodium chloride solution, 5% dextrose solution or water for injectable preparations. In patients not previously treated with opioids, administer a dose of 1 to 10 mg as a bolus, slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours.
• i.v. (infusion):dilute in 0.9% sodium chloride solution, 5% dextrose solution or water for injectable preparations. For patients not previously treated with opioids, a starting dose of 2 mg/hour is recommended.
• i.v. (PCA):dilute in 0.9% sodium chloride solution, 5% dextrose solution or water for injectable preparations. In patients not previously treated with opioids, a bolus dose of 0.03 mg/kg should be administered with a minimum lockout interval of 5 minutes.
• s.c. (bolus):dilute in 0.9% sodium chloride solution, 5% dextrose solution or water for injectable preparations. In patients not previously treated with opioids, a dose of 5 mg is recommended at intervals of 4 hours as needed.
• s.c. (infusion):dilute in 0.9% sodium chloride solution, 5% dextrose solution or water for injectable preparations as needed. In patients not previously treated with opioids, a starting dose of 7.5 mg/day is recommended, gradually titrating based on symptom control. In oncology patients who were taking oxycodone orally, much higher doses may be necessary (see below). Switching from oral oxycodone to parenteral oxycodone:The dose should be established considering that 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is only a guide to the necessary dose. Patient variability requires that the appropriate dose be carefully titrated for each patient. Elderly:Elderly patients should be treated with caution. Administration of the lowest dose with careful titration for pain control is recommended. Patients with renal or hepatic impairment:For these patients, the determination of the initial dose should follow a conservative approach. The recommended initial dose for adults should be reduced by 50% (for example, a total daily oral dose of 10 mg in opioid-naïve patients) and the dose should be adjusted for each patient to achieve adequate pain control based on the individual clinical situation. Paediatric population:There are no data on the use of oxycodone injectable solution in patients under 18 years of age.

Use in non-malignant pain:
Opioids are not the first-line therapy for chronic non-malignant pain and are not recommended as a single treatment either. Strong opioids have proven useful in relieving the following types of chronic pain: chronic osteoarthritis pain and pain due to intervertebral disc disease.

Route of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.

Objectives and discontinuation of treatment
Before starting treatment with Oxycodone, a treatment strategy including the duration and objectives of the treatment and a plan for discontinuation of treatment should be agreed upon with the patient and in accordance with pain management guidelines. During treatment, frequent contact between doctor and patient should be maintained to assess the need to continue treatment, consider discontinuation and adjust the dosage, if necessary. When a patient no longer needs oxycodone-based therapy, the dose should be reduced gradually to prevent withdrawal symptoms. In the absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of the underlying disease (see section 4.4 of the Summary of Product Characteristics) should be considered.

Duration of treatment
Oxycodone should not be used for longer than necessary.

Special precautions for disposal and handling
The vial is for single use for a single patient. The injection must be administered immediately after opening the vial, any unused residue must be discarded. Chemical and physical stability during use has been demonstrated for 24 hours at a temperature of 15-25 ºC.
From a microbiological point of view, the product must be used immediately. If not used immediately, the times and conditions of conservation before use are the responsibility of the user and generally should not exceed 24 hours at 2-8 °C, unless the reconstitution, dilution, etc. have taken place under controlled and validated aseptic conditions.
Oxycodone 50 mg/ml injectable solution, undiluted or diluted with 3 mg/ml with 0.9% sodium chloride solution p/v, 5% dextrose p/v or water for injectable preparations, is physically and chemically stable for a period longer than 24 hours at room temperature, when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubes and PVC or EVA infusion bags. Oxycodone 50 mg/ml injectable solution, undiluted or diluted with 3 mg/ml in infusion liquids and in contact with the various materials used in the studies, does not require protection from light.
Inappropriate handling of the undiluted solution after opening the original vial, or of the diluted solutions, may compromise the sterility of the product.
Refer to the Summary of Product Characteristics for further information.

Ossicodone Molteni 10 mg/ml, injectable solution or for infusion

Ossicodone hydrochloride
Equivalent Medicinal Product

Read this leaflet carefully before using this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effect occurs, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Ossicodone is and what it is used for
• 2. What you need to know before you are given Ossicodone
• 3. How Ossicodone will be given to you
• 4. Possible side effects
• 5. How to store Ossicodone
• 6. Contents of the pack and other information

1. What is Ossicodone and what is it used for

The abbreviated name ‘Ossicodone’ is used. It contains the active ingredient oxycodone hydrochloride. This
belongs to a group of medicines called painkillers (or ‘analgesics’).
Oxycodone is used for moderate to severe pain.

2. What you need to know before you are given Ossicodone

You must not be given Ossicodone if:

• you are allergic to oxycodone hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• you have breathing problems, such as ‘severe chronic bronchial obstruction’, ‘severe asthma’ or have ‘severe respiratory depression’ causing shortness of breath, cough or slower and weaker breathing;
• you have severe abdominal pain or a part of the intestine is not working properly (‘paralytic ileus’);
• you have heart problems caused by long-term lung disease (‘cor pulmonale’);
• you have moderate to severe liver problems;
• you have frequent constipation;
• you are under 18 years of age.

If any of the above warnings apply to you, do not use Ossicodone. If you are not sure, talk to your
doctor, pharmacist or nurse before you are given Ossicodone.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this medicine if:

• you are elderly or debilitated;
• you have reduced thyroid function (‘hypothyroidism’) - you may need a lower dose;
• you suffer from myxedema (a thyroid disorder, characterized by dryness, coldness and swelling of the skin, affecting the face and legs);
• you have a head injury, severe headache or feeling unwell - this may indicate an increase in pressure in the head;
• you have a reduced blood volume (‘hypovolemia’); this can occur as a result of severe internal or external bleeding, severe burns, excessive sweating, severe diarrhea or vomiting;
• you have low blood pressure (‘hypotension’);
• you have mental disorders resulting from intoxication (‘toxic psychosis’);
• you have gallbladder or bile duct disorders;
• you suffer from inflammation of the pancreas (which can cause severe abdominal or back pain); you have inflammatory bowel disorders;
• you have prostate problems;
• you feel weak or have dizziness, nausea or vomiting or have lost weight - these may be symptoms of adrenal gland dysfunction;
• you have breathing problems, such as ‘severe lung disease’ causing shortness of breath and cough;
• you have previously experienced withdrawal symptoms such as agitation or anxiety, tremors or sweating when you stopped taking alcohol or medicines;
• you have kidney problems;
• you have liver problems.

If any of the above warnings apply to you (or you are not sure), talk to your doctor before
you are given this medicine.

Tolerance, dependence and abuse
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers
can reduce the effectiveness of the medicine (you get used to the medicine, a phenomenon known as tolerance).
Repeated use of Ossicodone can also lead to dependence, abuse, and addiction, which can lead to
a potentially fatal overdose. The risk of these side effects may increase with a higher dose
and a longer duration of use.
Dependence or abuse can make you feel like you no longer have control over how much medicine you need
to take or how often you need to take it. You may feel like you need to continue taking the
medicine, even when it doesn't help relieve the pain.
The risk of becoming dependent or addicted varies from person to person. You may be at greater risk of becoming dependent or addicted to Ossicodone if:

• you or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”);
• you are a smoker;
• you have had mood disorders (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses. If any of the following signs appear while you are taking Ossicodone, this may indicate that you have become dependent or addicted:
• you need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you are using the medicine for reasons other than those prescribed, for example “to stay calm” or “to help you sleep”;
• you have repeatedly tried, without success, to stop or control the use of the medicine;
• when you stop taking the medicine you feel unwell, and you feel better after resuming taking it (“withdrawal effects”). If any of these signs appear, see your doctor to discuss the best treatment plan for you, including when it is appropriate to stop treatment and how to do so safely (see section 3 “If you stop taking Ossicodone”). Breathing-related sleep disordersOssicodone can cause breathing-related sleep disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to labored breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or another person observe these symptoms, see your doctor. The doctor may consider reducing the dose.

Children and adolescents
Do not use this medicine in children under 18 years of age.

For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.
Other medicines and Ossicodone
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines
including herbal medicines. This is because Ossicodone can change the effect of other
medicines. Other medicines can also change the effect of Ossicodone.
The concomitant use of Ossicodone Molteni and sedatives such as benzodiazepines or medicines related
to them increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can
be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Ossicodone Molteni together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
the doctor's recommendation on the dose. It may be helpful to tell friends or family to pay attention to
the signs and symptoms listed above. See a doctor if you experience these symptoms.

Do not use this medicine and tell your doctor or pharmacist if you are taking:

• medicines called ‘monoamine oxidase inhibitors’, such as tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid.

Tell your doctor or pharmacist if you are taking:

• some types of antidepressant medicines called monoamine oxidase inhibitors or if you have taken these medicines in the last two weeks;
• sleeping pills, such as tranquillizers, hypnotics or sedatives including benzodiazepines;
• medicines for depression;
• medicines for mental disorders, such as phenothiazines or neuroleptics;
• other potent painkillers or ‘analgesics’;
• medicines that relax muscles;
• medicines for high blood pressure;
• medicines for infections, such as clarithromycin, erythromycin or telithromycin;
• medicines for fungal infections, such as ketoconazole, voriconazole, itraconazole or posaconazole;
• a type of medicine for HIV called ‘protease inhibitors’, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• rifampicin (for the treatment of tuberculosis);
• carbamazepine (a medicine for the treatment of seizures and convulsions, and some types of pain);
• phenytoin (a medicine for the treatment of seizures and convulsions);
• cimetidine, used for stomach ulcers, indigestion or heartburn;
• quinidine, used for fast heartbeat;
• anaesthetics, used before an operation or medical procedure;
• an herbal remedy called St John's Wort (also known as Hypericum perforatum);
• antihistamines
• medicines for the treatment of Parkinson's disease

If any of the above conditions apply to you (or you are not sure), talk to your doctor or pharmacist before
you are given this medicine.

Ossicodone with food, drinks and alcohol

• Do not drink grapefruit juice while being treated with Ossicodone.
• Do not drink alcohol while being treated with Ossicodone. This is because it can cause drowsiness or increase the risk of serious side effects such as shallow breathing with the risk of respiratory depression and loss of consciousness.

Pregnancy and breastfeeding
Pregnancy
This medicine should not be used during pregnancy unless expressly
advised by your doctor, and should not even be administered during childbirth, as slow and shallow breathing (respiratory depression) or withdrawal symptoms may occur in the newborn.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before
you are given this medicine.

Breastfeeding
Do not breastfeed while taking Ossicodone. This is because the drug can pass into breast milk.

Driving and using machines
While taking Ossicodone, side effects such as drowsiness, weakness,
dizziness or loss of consciousness may occur. These are more common at the beginning of treatment or when switching to a higher dose. If you experience these symptoms, do not drive vehicles or use tools or machinery.

Ossicodone contains sodium
Ossicodone Molteni 10 mg/ml – 1 ml vial contains less than 1 mmol (23mg) of sodium per vial, that is
essentially ‘sodium-free’.
Ossicodone Molteni 10 mg/ml – 2 ml vial contains less than 1 mmol (23mg) of sodium per vial, that is
essentially ‘sodium-free’.
Ossicodone Molteni 10 mg/ml – 20 ml vial contains 57.0 mg of sodium (the main component of table salt) per vial. This corresponds to 2.85% of the recommended daily intake of salt
for an adult.

3. How to take Ossicodone

Before starting treatment and regularly during treatment, your doctor will talk to you about what you can
expect from using Ossicodone, when and for how long you should take it, when to contact your
doctor and when you should stop taking it (see also “If you stop taking Ossicodone”).
Ossicodone will be administered to you by a doctor or nurse. The injection must be administered immediately
after opening the vial.

Administration of the medicine
The injection can be administered in 3 ways:

• into a vein over a period of 1 to 2 minutes;
• with a subcutaneous needle;
• via ‘drip’ (infusion). How much medicine will be administered to you

The doctor will calculate the correct dose. The dose and frequency of injection administration may be
modified depending on the intensity of the pain.
Usually, the initial dose depends on the type of injection and will be calculated by the doctor.
Generally, the initial doses are:

• single injection intravenously, usually from 1 to 10 mg, administered slowly for 1-2 minutes. The doses will be administered at intervals of at least 4 hours from each other;
• single injection with a thin needle into the subcutaneous tissue, the recommended initial dose is 5 mg and is generally administered every 4 hours. Via ‘drip’ (also called infusion):
• an intravenous infusion, usually the initial dose is 2 mg per hour;
• an infusion with a thin needle into the subcutaneous tissue, usually the initial dose is 7.5 mg per day;
• a self-controlled infusion (‘patient-controlled analgesia’ or ‘PCA’), the dose depends on your weight (0.03 mg per kg of body weight). The frequency of drug administration will be established by the doctor or nurse. If pain persists during the use of Ossicodone, contact your doctor, pharmacist or nurse. Use in children and adolescentsThe medicine should not be used in case of age less than 18 years. Patients with kidney or liver problemsContact your doctor, pharmacist or nurse if you suffer from kidney or liver problems. This is because you may be given another medicine or a lower dose of ossicodone. If you are given too much Ossicodone or if the medicine is used by someone elseDo not use a dose of ossicodone higher than that prescribed by your doctor. If in doubt, check with your doctor or pharmacist. If you think you have been given too much medicine (‘overdose’), inform your doctor immediately and go to hospital immediately. Bring the medicine package with you. Do not drive vehicles and do not do anything that requires you to remain vigilant. In case of a drug overdose, the following symptoms may appear:
• reduction in pupil size;
• slower or weaker breathing than normal (respiratory depression);
• drowsiness or loss of consciousness;
• loss of muscle tone (hypotonia);
• slower pulse rate;
• lowering of blood pressure;
• a brain condition (known as toxic leukoencephalopathy). In severe cases, an overdose can lead to fainting (‘loss of consciousness’) or death. If you stop taking OssicodoneDo not suddenly stop using this medicine unless your doctor has told you to. If you want to stop using this medicine, discuss it with your doctor first. The doctor will be able to tell you the correct way to do it. Usually, the dose should be reduced gradually, in order to avoid unwanted effects. The following symptoms may occur if you suddenly stop using this medicine:
• state of anxiety or agitation;
• palpitations;
• tremor;
• sweating.

For further information on the use of this medicine, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this injection can cause side effects, although not everybody gets them.

Serious side effects
Stop taking Ossicodone and contact your doctor immediately if any of the following serious side effects occur:

• allergic reactions - symptoms may include wheezing, difficulty breathing, swelling of eyelids, face or lips, skin rash or itching - these can affect the whole body;
• breathing problems (symptoms may include slow and shallow breathing).

If any of the above serious side effects occur, stop taking
ossicodone and contact your doctor immediately.

Other side effects
Contact your doctor, pharmacist or nurse if any of the following side effects occur:

Very common:may affect more than 1 in 10 people

• constipation - your doctor may prescribe a medicine to help with this problem;
• Nausea or vomiting - usually disappear within a few days. If this does not happen, your doctor may prescribe you medicines that can help;
• drowsiness - this is more likely to happen at the beginning of treatment or when the dose is increased, but should disappear after a few days;
• headache;
• dizziness;
• itching.

Common:may affect up to 1 in 10 people

• dry mouth, loss of appetite, indigestion, pain or discomfort in the stomach, diarrhea;
• confusion, depression, weakness, tremors, lack of energy, fatigue, anxiety or nervousness, difficulty sleeping, strange thoughts or dreams;
• wheezing or difficulty breathing, shortness of breath, inability to cough normally;
• skin rash;
• sweating. Uncommon:may affect up to 1 in 100 people
• allergic reactions;
• difficulty breathing;
• fast and irregular heartbeat, flushing;
• feeling dizzy; seeing or hearing things that are not real (hallucinations), mood swings unpleasant or uncomfortable feeling of euphoria, restlessness, agitation or general malaise, memory loss;
• difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness in hands and feet, convulsions, changes in vision, fainting, unusual muscle stiffness or relaxation, involuntary muscle contractions;
• dry skin, severe peeling or flaking of the skin;
• dehydration, feeling thirsty, chills, sweating of hands, ankles or feet;
• facial flushing, decreased pupil diameter, muscle spasms, high temperature;
• difficulty swallowing, belching, hiccups, flatulence, a condition in which the intestine does not work properly (ileus), stomach problems, changes in the taste of food;
• difficulty urinating, problems with erection, decreased sexual desire, low levels of sex hormones in the blood (hypogonadism, detectable by blood tests);
• need to take higher doses of medicine than normal to get the same amount of pain relief (tolerance): as with all strong painkillers, there is a risk of becoming addicted or tolerant to this medicine, withdrawal symptoms (see section 2 “Warnings and precautions”);
• changes in liver function tests, biliary colic

Rare side effects

• low blood pressure
• feeling faint, especially when getting up;
• urticaria

Frequency not known:the frequency cannot be estimated based on available data

• increased sensitivity to pain;
• aggressiveness;
• dental caries
• absence of menstrual cycle
• a blockage of the flow of bile from the liver (cholestasis). This can cause itching of the skin, yellowish skin, very dark urine and very pale stools;
• Long-term use of Ossicodone Molteni during pregnancy can cause potentially fatal newborn withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and altered sleep patterns, acute crying, tremors, diarrhea and failure to gain weight.
• Sleep apnea (pauses in breathing during sleep).

If any of the above side effects occur, contact your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Ossicodone

Keep this medicine out of the sight and reach of children. Store this medicine in a secure location, inaccessible to others. It may cause serious harm and be fatal to people for whom it was not prescribed.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after “Exp.”.
This medicine does not require any particular storage temperature. Store in the original packaging to protect the medicine from light. Once the vial has been opened, the injection should be administered immediately. Any unused medicine should be disposed of immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossicodone contains

• The active ingredient is oxycodone hydrochloride.
• The other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, diluted hydrochloric acid, sodium hydroxide, water for injections. Ossicodone Molteni contains a component with known effects (sodium). See section 2.

Description of the appearance of Ossicodone and contents of the pack
This injection is a clear and colorless solution supplied in transparent glass vials.
The 10 mg/ml concentration is available in vials of 1 ml, 2 ml, 20 ml of solution (containing
respectively 10 mg, 20 mg and 200 mg of oxycodone hydrochloride).

Marketing Authorisation Holder and Manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA - Strada Statale 67, Fraz. Granatieri - 50018 Scandicci (Florence) – Italy Tel: +3905573611 Fax: +39055720057 e-mail: [email protected] This medicinal product is authorised in the Member States of the European Economic Area with the following designations: Oxycodone Molteni 10 mg/ml, solution injectable or pour perfusion France Oxycodone Molteni 10 mg/ml, solution for injection or infusion United Kingdom Oxycodone Molteni Poland

 ----------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals
Ossicodone Molteni 10 mg/ml, injectable solution or for infusion
Oxycodone hydrochloride
Molteni 10 mg/ml, injectable solution or for infusion.

Posology and method of administration

Posology:
The dose should be adjusted according to the intensity of the pain, the patient's general condition and previous or current therapeutic treatment.

Adults over 18 years:
The following initial doses are recommended for patients not previously treated with opioids. The initial dose should be adjusted according to previous or current therapeutic treatment (especially if the patient
has been previously treated with other opioids), the patient's general condition and the intensity of the
pain. If insufficient analgesia or increased pain intensity occurs, it may be necessary to
gradually increase the dose.

• i.v. (bolus):dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose or water for injections. Administer a dose of 1 to 10 mg as a bolus, slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours
• i.v. (infusion):dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended.
• i.v. (PCA):dilute to 1 mg/ml in 0.9% sodium chloride solution, 5% dextrose or water for injections. A bolus dose of 0.03 mg/kg should be administered with a minimum lockout interval of 5 minutes.
• s.c. (bolus):use the 10 mg/ml concentration as is. A starting dose of 5 mg is recommended, repeating at intervals of 4 hours as needed.
• s.c. (infusion):dilute in 0.9% sodium chloride solution, 5% dextrose or water for injections as needed. In patients not previously treated with opioids, a starting dose of 7.5 mg/day is recommended, titrating gradually based on symptom control. In oncological patients who were taking oxycodone orally, much higher doses may be necessary (see below). Switching from oral oxycodone to parenteral oxycodone:

The dose should be established considering that 2 mg of oral oxycodone is equivalent to 1 mg of oxycodone
parenterally. It should be emphasized that this is only a guide to the necessary dose. Patient variability requires that the appropriate dose be carefully titrated for each patient.

Elderly:
Administration of the lowest dose with careful titration for pain control is recommended.

Patients with renal or hepatic impairment:
For these patients, the determination of the initial dose should follow a conservative approach.
The recommended initial dose for adults should be reduced by 50% (for example, a total daily oral dose of 10 mg in opioid-naive patients) and the dose should be adjusted for each patient to
achieve adequate pain control based on the individual clinical situation.

Paediatric population:
There are no data on the use of oxycodone injectable solution in patients under 18 years of age.

Use in non-malignant pain:
Opioids are not the first-line therapy for chronic non-malignant pain and are not recommended
as a single treatment either. Strong opioids have proven useful in relieving the following types of chronic pain: chronic osteoarthritis pain and pain due to intervertebral disc disease.

Method of administration
Subcutaneous injection or infusion.
Intravenous injection or infusion.

Objectives and discontinuation of treatment
Before starting treatment with Ossicodone, a treatment strategy including the duration and objectives of the treatment and a plan for discontinuation of treatment should be agreed with the patient and in accordance with pain management guidelines. During treatment, frequent contact between doctor and
patient should be maintained to assess the need to continue treatment, consider discontinuation and adjust the dosage, if necessary. When a patient no longer needs
opioid-based therapy, it is advisable to reduce the dose gradually to prevent withdrawal symptoms. In the absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of the underlying disease should be considered (see section 4.4 of the Summary
of Product Characteristics).

Duration of treatment
Ossicodone should not be used for longer than necessary.

Special precautions for disposal and handling
The vial is for single use for a single patient. The injection must be administered immediately after
opening the vial, any unused residue must be discarded. Chemical-physical stability during use
has been demonstrated for 24 hours at a temperature of 15-25 ºC.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility of the user
and generally should not exceed 24 hours at 2 and 8 °C, unless reconstitution, dilution, etc. have been
carried out under controlled and validated aseptic conditions.
Ossicodone injectable solution, undiluted or diluted to 1 mg/ml with 0.9% p/v sodium chloride solution, 5% p/v dextrose
or water for injections, is physically and chemically stable for a period longer than
24 hours at room temperature, when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubes and PVC or EVA infusion bags. Ossicodone injectable solution, undiluted or
diluted to 1 mg/ml in infusion fluids and in contact with the various materials used in the studies, does not require
protection from light.
Inappropriate handling of the undiluted solution after opening the original vial, or of the
diluted solutions, may compromise the sterility of the product.
Refer to the Summary of Product Characteristics for further information.